Auditor

LOCATION
Japan, Remote

ENGAGEMENT TYPE
Freelance, contractor, project based

FUNCTION
Quality, Audit, Life Sciences Consulting

OVERVIEW

ProPharma is seeking experienced freelance life sciences auditors based in Japan to support upcoming client audit activity on a project based contractor basis.

We are interested in speaking with senior quality, compliance, clinical research, pharmacovigilance, PMS, GVP, GPSP, and GMP professionals who have hands on audit experience in Japan.

This opportunity may suit candidates with experience in one or more of the following areas:

GCP audits, including investigator site audits, CRO audits, vendor audits, sponsor process audits, or clinical quality systems
GVP, GPSP, PMS, pharmacovigilance, safety, case processing, call center, or post marketing related audits
GMP audits, including small molecule API, manufacturing, supplier, vendor, or quality system audits

The work may include onsite, remote, or hybrid audit activity depending on the assignment, client requirements, and auditor availability.

This is not a permanent employee position. Assignments will be offered on a freelance contractor basis, typically linked to specific client audit needs.

KEY RESPONSIBILITIES

• Plan, conduct, and report audits in line with applicable regulations, client requirements, and internal procedures.
• Perform audits across relevant life sciences environments, including clinical research, pharmacovigilance, PMS, GVP, GPSP, GMP, vendors, suppliers, sites, CROs, and outsourced service providers.
• Review operational processes, documentation, quality systems, vendor oversight, and compliance controls.
• Identify audit findings, assess compliance risk, and prepare clear, well structured audit reports.
• Support follow up activities, including review of root cause analysis, CAPA responses, and closeout actions.
• Engage professionally with clients, auditees, and internal stakeholders.
• Support onsite audit activity within Japan where required.
• Deliver audit work independently while maintaining appropriate auditor objectivity and professional judgement.

REQUIRED EXPERIENCE

• Proven experience conducting audits within pharmaceutical, biotechnology, CRO, vendor, supplier, clinical research, pharmacovigilance, PMS, GVP, GPSP, GMP, or related life sciences environments.
• Strong working knowledge of applicable Japanese regulations and quality expectations in at least one relevant audit area.
• Experience preparing audit reports and managing findings through follow up and CAPA review.
• Ability to work independently on project based audit assignments.
• Native level Japanese language capability.
• Business level English, especially for written communication, audit documentation, client communication, or report preparation.
• Based in Japan and able to support onsite audit work when required.

SPECIALIST EXPERIENCE OF INTEREST

• We are particularly interested in auditors with experience in one or more of the following areas:
• ICH GCP and Japanese GCP
• Investigator site audits
• CRO, vendor, or outsourced clinical service audits
• Sponsor process audits
• Inspection readiness or mock inspections
• Japanese GVP and GPSP
• PMS monitoring support
• PMS data management
• Pharmacovigilance quality systems
• Case processing operations
• Call center operations related to medical information, safety, or pharmacovigilance
• Vendor audits for pharmacovigilance, PMS, or safety operations
• GMP audits for small molecule API sites
• Manufacturing quality systems
• Supplier or vendor qualification audits
• API, drug substance, or related manufacturing audit experience

PREFERRED EXPERIENCE

• Experience working as an independent consultant, contractor, or freelance auditor.
• Experience supporting international clients or global quality teams.
• Experience conducting audits in both Japanese and English environments.
• Experience with onsite audit delivery in Japan.
• Experience reviewing audit logs, audit plans, CAPA responses, and inspection readiness documentation.
• Ability to support short term or intermittent audit assignments throughout the year.

PERSONAL PROFILE

• Clear and credible communicator.
• Professional in front of clients and auditees.
• Comfortable working independently.
• Able to assess compliance risk and materiality of findings with sound judgement.
• Able to manage timelines, deliverables, and documentation accurately.
• Practical, flexible, and commercially aware when supporting project based client work.

ENGAGEMENT DETAILS

This is a freelance contractor opportunity. Specific assignments will depend on client requirements, audit scope, location, timing, and auditor availability.

Candidates do not need to have experience across all audit types listed above. Experience in one strong specialist area, such as GCP, GVP/GPSP, PMS, pharmacovigilance, or GMP, may be sufficient depending on the project.